Multicentre pragmatic randomised controlled feasibility trial of fertiShare, a brief eLearning course to increase fertility staff performance when sharing bad news with their patients - a protocol

一项多中心实用性随机对照可行性试验,旨在评估 fertiShare(一种简短的在线学习课程)在向患者告知坏消息时提升生育医护人员表现方面的有效性——一项方案

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Abstract

INTRODUCTION: Sharing bad news (SBN) is a recurring and stressful challenge for fertility staff and patients. Suboptimal SBN is associated with staff burnout, patient dissatisfaction with care and lack of trust in staff, potentially leading to patient discontinuation. Patients value staff having SBN skills, but staff feel unprepared to do this task. fertiShare is a 2-hour bespoke eLearning course to support fertility staff in SBN with their patients, organised into three modules, with each module offering video content-based lessons, simulated case studies showing optimal and suboptimal approaches to SBN and brief quizzes for self-reflection and assessment. This protocol aims to evaluate if it is feasible to implement fertiShare at UK-based fertility clinics and if it is acceptable to staff and patients. METHODS AND ANALYSIS: Multicentre, two-arm, parallel-group, blinded, feasibility randomised controlled trial with 1:1 randomised staff allocation to fertiShare (intervention group) or general communication skills eLearning (control group). Six UK-based clinics, 60 staff spending a minimum of 10% week-time SBN and 360 patients having received bad news from participating staff within the last month will be recruited. Two cohorts of patients will be recruited, one after staff consent to the study and before fertiShare or control eLearning course (pretraining patient cohort) and another 1-month post staff training (post-training patient cohort). Outcome measures relate to demand, acceptability, implementation, practicality and limited efficacy testing, with the primary outcome being staff performance when SBN, reported by patients using an adapted version of the SBN Behavioural Assessment Scale. Recruitment and data collection will span from September 2025 to February 2026. ETHICS AND DISSEMINATION: The study was approved by the National Health Service Research Ethics Committee (23/LO/0864) and the Cardiff University - School of Psychology Research Ethics Committee (EC.23.08.08.6827). Results will be disseminated via publications in peer-reviewed journals, conference presentations and public engagement, and will inform if fertiShare should proceed to efficacy evaluation. Insights from this study can inform the implementation of other SBN training in fertility or other healthcare domains and improve understanding of the impact SBN training has on patient experience and outcomes. TRIAL REGISTRATION NUMBER: NCT06587360, https://www. CLINICALTRIALS: gov/.

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